Clinical Research Directory

Comparison of Two Autologous Sling Procedures for Stress Urinary Incontinence in Women

This study compares two operations for stress urinary incontinence in adult women. Stress urinary incontinence means leaking urine during activities such as coughing, sneezing, laughing, or exercising. Women with both stress-related leakage and a sudden urgent need to urinate were also eligible if stress-related leakage was their main problem. Both operations use the woman's own tissue to create a sling that supports the urethra, the tube that carries urine out of the bladder. One operation uses tissue from the vaginal wall, placed through openings in the pelvic bones near the groin (a transobturator vaginal wall sling). The other uses tissue from the strong layer covering the abdominal muscles (a rectus sheath pubovaginal sling). Neither operation uses synthetic mesh, although permanent supporting stitches are used. Forty women at Kafrelsheikh University Hospitals, Egypt, were randomly assigned to one of the two operations, with 20 women in each group. Follow-up continued for six months after surgery. The main question is whether the operations differ in preventing urine leakage during a cough test six months after surgery. The study also compares urinary symptoms, operation duration, urine flow, bladder emptying, and complications.

Anterior Bridge-Preserving Versus Conventional Early Apical Release in Bipolar Enucleation of the Prostate

Bipolar enucleation of the prostate is an effective operation for men with urinary obstruction caused by a benign enlarged prostate. Some men leak urine for a period after the operation. Early apical release is a surgical step that frees the tip (apex) of the prostate at the start of the operation to reduce stretch on the urinary sphincter. The conventional technique cuts all the way around the apex, including the front (anterior) tissue next to the sphincter. This randomized trial compares a modified technique, Anterior Bridge-Preserving Semicircular Early Apical Release (ABP-S-EAR), with conventional early apical release. ABP-S-EAR leaves the front tissue bridge between the 11 and 1 o'clock positions intact. Men aged 45 to 80 years scheduled for bipolar enucleation at Benha University Hospital, Egypt, will be randomly assigned to one technique. The main question is whether ABP-S-EAR improves urinary continence 1 month after surgery. The trial also compares patient-reported leakage, operative time, bleeding, catheter time, hospital stay, urinary symptoms, urine flow, and complications over 12 months.

Comparing the Effect of Two Types of Pelvic Floor Muscle Stimulation Devices to Improve Symptoms of Urinary Incontinence in Women.

This randomized, parallel-group, non-inferiority clinical trial will compare electromagnetic chair therapy with standard electrostimulation combined with biofeedback in 58 adult women with mixed urinary incontinence. Participants will be randomized 1:1 to receive 12 treatment sessions over six weeks. Clinical outcomes will be assessed at baseline, at the end of treatment (week 6), and at week 30. The primary endpoint is the change from baseline to week 6 in the average daily number of total urinary incontinence episodes, recorded in a three-day bladder diary. Secondary outcomes include changes in urgency and stress urinary incontinence episodes, voiding frequency, nocturia, pad use, ICIQ-UI SF scores, patient-reported improvement, responder rates, and urodynamic parameters. Safety and treatment adherence will also be evaluated throughout the study.

A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)

Prospective, multicenter, single-arm study

The Effects of Expiratory Muscle Strength Training in Women With Stress Urinary Incontinence

The aim of this study is to investigate the effects of expiratory muscle strength training in addition to pelvic floor muscle training in women with stress urinary incontinence. In this study, women will be randomly assigned to one of two separate intervention groups. One group is the Pelvic Floor Muscle Training (PFMT) group, and the other is the PFMT plus Expiratory Muscle Strength Training group. The intervention program will last 8 weeks in both groups. Women in both groups will be evaluated at the beginning of the study (before the interventions) and at the end of the 8th week of intervention. After being taught the exercises included in the PFMT program, both groups will be asked to perform these exercises as a home program. The accuracy of the exercises performed by the women will be checked at two-week intervals, and the number of exercises will be increased. The primary outcome measure is the International Incontinence Consultation Questionnaire-Short Form (ICIQ-UI SF), which measures the Subjective Severity of Incontinence and its Impact on Daily Living.

Pelvic Floor Muscle Exercise and Progressive Muscle Relaxation for Stress Urinary Incontinence

Stress urinary incontinence (SUI) is a common condition in women that causes involuntary urine leakage during activities such as coughing, sneezing, laughing, or exercising. This condition can negatively affect physical, emotional, and social well-being and reduce overall comfort. Pelvic floor muscle exercise (PFME) is the recommended first-line conservative treatment for SUI, while progressive muscle relaxation (PMR) may help reduce muscle tension and improve psychological well-being. However, the combined effects of these two interventions on comfort have not been well studied. This randomized controlled trial aims to compare the effects of PFME, PMR, their combined application, and routine care on comfort in women with stress urinary incontinence. Participants will be randomly assigned to one of four study groups and followed for six weeks. Comfort will be assessed at baseline and at Weeks 2, 4, and 6 using a validated questionnaire. The findings are expected to provide evidence for improving conservative treatment strategies and enhancing patient-centered care for women with stress urinary incontinence.

Optimization of Surgical Treatment Pathways for BPH Based on Real-World Data

Benign prostatic hyperplasia is a noncancerous enlargement of the prostate that can cause difficulty urinating. Holmium laser enucleation of the prostate (HoLEP) uses a laser to remove prostate tissue blocking urine flow. Some patients experience stress urinary incontinence after surgery, meaning urine leakage during activities such as coughing, sneezing, or physical exertion. This may be related to temporary dysfunction or injury of the muscle that controls urine release. This single-center, prospective randomized study compares three HoLEP techniques in men aged 50-85 years with benign prostatic hyperplasia: conventional HoLEP without apical pre-disconnection; HoLEP with apical pre-disconnection at a fixed 12 o'clock location; and HoLEP with MRI-guided individualized apical pre-disconnection. Apical pre-disconnection involves separating the urethral lining near the tip of the prostate before the main tissue removal step. In the individualized group, preoperative magnetic resonance imaging (MRI) is used to tailor the separation site to each patient's anatomy. The study tests the hypothesis that MRI-guided individualized apical pre-disconnection reduces postoperative stress urinary incontinence and improves early urinary control and quality of life compared with the other two techniques, while maintaining the improvement in urination achieved by HoLEP. Participants are randomly assigned to one of the three surgical groups and assessed at 1 week, 1 month, and 3 months after surgery. The primary outcome is the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF) total score at 3 months. This questionnaire measures the frequency and amount of urine leakage and its impact on daily life. Secondary outcomes include ICIQ-UI-SF scores at 1 week and 1 month, and quality of life, urinary symptoms, maximum urine flow rate, and postvoid residual urine volume at all three follow-up visits. Postoperative complications are also recorded and compared among groups.

Motor Imagery-Assisted Pelvic Floor Muscle Training for Stress Urinary Incontinence in Postmenopausal Women

This study will evaluate whether adding mental rehearsal of pelvic floor muscle contractions to pelvic floor muscle training improves stress urinary incontinence in postmenopausal women. Stress urinary incontinence is urine leakage during activities such as coughing, sneezing, or physical exertion. Mental rehearsal involves imagining the sensation of a movement without physically performing it. The study will include 60 women aged 45 to 65 years who have completed natural menopause and have stress urinary incontinence. Participants will be randomly assigned to one of two groups. Both groups will receive the same supervised pelvic floor muscle training twice a week for 12 weeks. Before performing the pelvic floor exercises, one group will imagine contracting and relaxing the pelvic floor muscles. The other group will imagine making and opening a fist with their dominant hand. Assessments will take place before treatment and at the end of 12 weeks. The main outcome will be urinary incontinence symptom severity. Additional assessments will examine urine leakage frequency and amount, incontinence-related quality of life, and pelvic floor muscle electrical activity.

Vaginal Prasterone Versus Estriol in Women With Pelvic Floor Disorders

This prospective, non-randomized comparative study evaluated the effects of short-term vaginal treatment with prasterone or estriol in women with pelvic floor disorders who were awaiting urogynecological surgery. A total of 74 women were included, with 37 participants receiving vaginal prasterone and 37 receiving vaginal estriol. Treatment was administered before surgery for approximately 8 weeks. The study assessed changes in pelvic floor symptoms and quality of life using the WHOQOL-BREF questionnaire and symptom severity scales. The aim was to compare the effects of the two vaginal treatments on symptoms and quality of life before urogynecological surgery.

Laser Therapy and Pelvic Floor Muscle Training for Stress Urinary Incontinence

The aim of this study was to investigate the effects of Pelvic Floor Muscle Training (PFMT) in addition to high-intensity laser therapy (HILT) on pelvic floor dysfunction, sexual dysfunction, and quality of life in women with stress urinary incontinence. Women with SUI will be randomly assigned to PFMT (Group I), Laser + PFMT (Group II), and placebo laser (Group III). PFMT will be administered twice weekly for 12 weeks under the supervision of a physiotherapist. PFMT will be administered with biofeedback. HILT will be applied to six points in the perineal region . The intensity will be 6W, the energy density will be 120J/cm2, and three sessions will be administered weekly for a total of six sessions. Women included in the study will be evaluated twice, at the beginning and at the end of the treatment, with the Incontinence Quality of Life Scale (I-QOL), Incontinence Severity Index (ISI), Female Sexual Function Scale-(FSFI), and Global Pelvic Floor Impact Questionnaire (GPTRA).

Pivotal Study of Voro Urologic Scaffold

The objective of this study is to compare safety and effectiveness of the Voro Urologic Scaffold in adult men undergoing robotic assisted radical prostatectomy as compared to control arm. The study is a multi-center, single blind, randomized, controlled trial. Up to 266 participants will be treated at up to 30 centers in the United States. The study will consist of a Baseline visit, implantation during robotic assisted radical prostatectomy (RARP), catheter removal, 6 weeks, 6 months, 12 months, 18 months, and 24 months.

Suzetrigine for Opioid-Sparing Postoperative Analgesia Following Transvaginal Pelvic Reconstructive Surgery

Suzetrigine is a selective NaV1.8 inhibitor that provides peripheral analgesia without opioid-related CNS effects. This single-center stepped-wedge randomized clinical trial evaluates whether a suzetrigine-based postoperative analgesic regimen provides non-inferior pain control compared with standard opioid-inclusive care following transvaginal pelvic reconstructive surgery. The study will enroll 120 participants and assess pain, opioid consumption, adverse events, and functional recovery.

The Effect of Different Delivery Positions on Pelvic Floor Function.

This study is a prospective, multicenter, randomized controlled trial. Baseline data will be collected from eligible subjects recruited during the third trimester of pregnancy. Participants will be randomized into three groups when cervical dilation reaches 2 cm based on delivery position: lithotomy position, upright position, and lateral position. During the second stage of labor, data regarding delivery positions, duration of each position, and other obstetric conditions will be recorded. Pelvic floor function assessments will be performed in the postpartum period to evaluate the outcomes.

Long-term Outcomes of Urethral Ligament Plication and Transvaginal Tape Surgery

In the treatment of urinary incontinence caused by coughing, sneezing, or heavy lifting, the investigators will perform urinary tract tightening surgery, both with and without a sling, to address the relaxed urinary tract. The investigators would like to evaluate the one-year success and results of the sling or non-sling urinary tract tightening surgery the investigators will perform on the participants.

Dynamic Neuromuscular Stabilization Exercises in Women With Urinary Incontinence

Stress urinary incontinence (SUI) is defined by the International Continence Society as the complaint of involuntary leakage of urine during physical exertion, including sports activities, or during sneezing or coughing. In continent women, an automatic response-namely, a reflex pelvic floor muscle (PFM) contraction, also known as pre-contraction-occurs either prior to or during physical exertion. Although there is strong evidence supporting the effectiveness of pelvic floor muscle training (PFMT) in the treatment of SUI, there has been a growing interest in exploring alternative exercise-based interventions. Dynamic Neuromuscular Stabilization (DNS) is a manual and rehabilitative approach developed by Professor Pavel Kolar. It is grounded in the scientific principles of developmental kinesiology and aims to optimize the function of the movement system. Currently, DNS is successfully employed in the rehabilitation of various neurological, musculoskeletal, pediatric, and sports-related injuries. DNS incorporates the subconscious and synergistic activation of the deep core muscles responsible for intra-abdominal pressure (IAP) regulation and spinal stability-namely, the diaphragm, transversus abdominis, multifidus, and pelvic floor muscles-as well as the global musculature. Considering the potential mechanisms of DNS, we hypothesize that DNS exercises, through IAP regulation directed toward the pelvic cavity and contributing to stabilization, could serve as an effective and innovative approach for women with SUI. The hypotheses of this study are as follows: H1.1: DNS is as effective as PFMT in reducing urinary symptoms in women with SUI. H1.2: DNS is as effective as PFMT in improving PFM function in women with SUI.

Effect of Hypo-pressive Exercises and Pelvic Floor Muscle Training in Postpartum Stress Urinary Incontinence Women

Postpartum stress urinary incontinence is a widespread condition characterized by involuntary loss of urine during physical exertion, such as sneezing, coughing, or lifting heavy weights. Most frequently occur in multiparous women with vaginal delivery, who are obese, constipated, or with low maternal education. Damage to the levator ani muscle complex and adjacent fascia during childbirth affects urethral mobility and consequently results in sphincter insufficiency. Hypopressive exercises involve breathing techniques that regulate the intra-abdominal pressure. HE has been recently recognized for benefits such as pelvic floor muscle (PFM) strength, endurance, postural control, core muscle activation, and respiratory capacity, which efficiently improve symptom severity and quality of life in postpartum women. Pelvic floor muscle training (PFMT) is a set of frequent voluntary contractions designed to improve strength, coordination, and control. PFMT is considered as standard treatment protocol for urinary incontinence and other postpartum complications. The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-UI-SF) and the Incontinence Quality of Life (IQOL) are used to assess symptom severity and quality of life, respectively. This study seeks to bridge that gap by evaluating and comparing the outcomes of HE and PFMT in postpartum women experiencing SUI. This research aims to support postpartum recovery, improve women's daily functioning, and enhance their overall well-being.

Hybrid Transobturator Tape Versus Conventional Synthetic Tape for Stress Urinary Incontinence

This randomized controlled trial compares the safety, efficacy, and impact on female sexual function of a novel hybrid transobturator tape (combining an autologous rectus fascia strip with a polypropylene mesh) versus standard synthetic transobturator tape in women undergoing surgery for stress urinary incontinence.

The Effect of Periurethral Injection of Platelet Rich Plasma Versus Mid-urethral Sling in Treatment of Stress Urinary Incontinence

this study used to compare efficacy between platelet rich plasma periurethral injection versus mid urethral sling ( trans obturator tape ) in treatment of stress urinary incontinence

A Study of Two Versions of the Uresta Pessary Handle for Women With Stress Urinary Incontinence

The goal of this clinical trial is to learn if a new handle design for the uresta pessary works better than the current handle design for women when they are using the pessary. The main questions it aims to answer are: Is the new pessary equally effective for users. Do pessary users find the new handle design is more or less helpful for insertion and removal of the pessary Is the optional removal string, provided with the new handle, helpful in pessary handling. The participants will use both the original and the new uresta pessary handle designs and complete a questionnaire to rate both handles. The score for the two questionnaires will be compared to determine which handle is best.

Differences in Pelvic Floor Motion Level Among Chinese Women and Construction of an Assessment System

The purpose of this study is to integrate millimeter-wave radar technology to investigate the dynamic movement characteristics of the pelvic floor muscles in patients with different Body Mass Index (BMI) and stress urinary incontinence. Based on this, a large database of pelvic floor movement parameters for Chinese women will be constructed, and a multi-subgroup standard atlas of pelvic floor muscle movement will be established to promote the standardized application of this technology in obstetrics and gynecology clinical assessments. This study also aims to explore the clinical value of pelvic floor movement assessment within the pelvic floor evaluation system, providing directions and insights for establishing a systematic evaluation system and standardizing the diagnosis and treatment of pelvic floor disorders.

Development and Validation of a Risk Prediction Model for De Novo Stress Urinary Incontinence After Pelvic Floor Reconstruction Surgery

This observational study aims to develop a predictive model for the occurrence of new-onset stress urinary incontinence (SUI) after pelvic organ prolapse (POP) repair surgery in women. The primary questions it seeks to answer are: Which risk factors and anatomical characteristics predispose women to new-onset stress urinary incontinence following pelvic organ prolapse repair surgery? Female POP patients without any preoperative symptoms of urinary incontinence will receive telephone follow-ups at 3, 6, and 12 months after undergoing standard surgical treatment.

Augmenting Urinary Reflex Activity Study 4 (Including eXtended Indications)

Exploratory safety and feasibility study of personalized adaptive pudendal neuromodulation for mixed urinary incontinence and extended indications using an implanted (Picostim™ II) system.

Baseline Knowledge of Stress Urinary Incontinence Among Urogynecology Patients

The goal of this prospective study is to assess whether a standardized educational flyer (pamphlet) improves knowledge about stress urinary incontinence (SUI) in adult females attending a urogynecology clinic. It will also explore how participant characteristics relate to treatment preferences. The main questions it aims to answer are: Does reading a standardized SUI patient information flyer improve participants' knowledge of SUI? How do patient characteristics influence treatment preferences for SUI? Participants will: Complete a self-administered questionnaire assessing knowledge of SUI, including its definition, pathophysiology, risk factors, natural history, and treatment options (this questionnaire is not part of standard care). Review a standardized SUI educational flyer during their clinic visit. Complete the same questionnaire again after reading the pamphlet to assess any change in knowledge. Questionnaire scores before and after reading the flyer will be compared. Secondary outcomes include participant characteristics and reported treatment preferences.

Effects of Diaphragmatic Breathing With Kegal Exercises on Pelvic Floor Muscle Function and Quality of Life Among Multigravida Women With Stress Incontinence

The goal of this clinical trial is to determine the effect of diaphragmatic breathing with kegel exercises on pelvic floor muscle function and quality of life among multigravida women with stress urinary incontinence The main question it aims to answer are The effect of diaphragmatic breathing in combination with Kegel exercises is significant in improving pelvic floor muscle function and quality of life among multigravida women with stress urinary incontinence. The researcher will compare diaphragmatic breathing to kegel exercises as a standard treatment to see if it produces better results for treating SUI Participants will Perform diaphragmatic breathing with kegel exercises for 6 weeks Visit clinic every at the end of every week They will keep a diary regarding when they performed exercises